Intrauterine device

ABSTRACT

An intrauterine device for applying pressure to the walls of the uterine cavity includes a resilient body having an elongated member which includes a first end and a second end which are resiliently biased away from each other. The first end of the elongated member includes a first leg having a first end and a second end. The second end of the elongated member includes a second leg having a first end and a second end. A connection member is positioned between the first end of the first leg and the first end of the second leg. A first plug member is secured at the second end of the first leg and a second plug member is secured at the first end of the second leg. The first and second plug members are shaped and dimensioned for bearing against the walls of the uterine cavity as the elongated member spreads outwardly with the first end and the second end moving apart. A method for preventing conception within the uterine cavity is also disclosed.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 12/353,770, filed Jan. 14, 2009, entitled “INTRAUTERINEFALLOPIAN TUBE OCCLUSION DEVICE”, which is currently pending, the '770application claims the benefit of U.S. Provisional Application Ser. No.61/006,454, filed Jan. 15, 2008, entitled “INTRAUTERINE FALLOPIAN TUBEOCCLUSION DEVICE”, and the '770 application is a continuation-in-part ofU.S. patent application Ser. No. 11/892,560, filed Aug. 23, 2007,entitled “INTRAUTERINE FALLOPIAN TUBE OCCLUSION DEVICE”, which is nowU.S. Pat. No. 7,621,276, which is continuation-in-part of U.S. patentapplication Ser. No. 11/884,027, filed Aug. 9, 2007, entitled“INTRAUTERINE FALLOPIAN TUBE OCCLUSION DEVICE AND METHOD FOR USE”, whichis now U.S. Pat. No. 7,669,601, which is the National Stage ofInternational Application No. PCT/US2006/005245, filed Feb. 15, 2006,entitled “INTRAUTERINE FALLOPIAN TUBE OCCLUSION DEVICE AND METHOD FORUSE”, which claims the benefit of U.S. Provisional Patent ApplicationSer. No. 60/653,743, filed Feb. 15, 2005, entitled “INTRAUTERINEFALLOPIAN TUBE OCCLUSION DEVICE”.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention relates to an intrauterine device and method for use. Moreparticularly, the invention relates to an intrauterine device that usesthe unique shape of the uterine cavity to ensure delivery and properpositioning thereof. The intrauterine device employs plug members forbearing against the wall of the uterus in a manner preventingconception. The invention also relates to a delivery mechanism utilizingthe device described herein to deliver medication and/or othertherapeutic agents to the uterus and/or fallopian tube anatomy.

2. Description of the Related Art

Several types of intrauterine devices (IUDs) are available and usedworldwide. There are inert IUDs, copper IUDs and hormone impregnatedIUDs. There is ongoing controversy regarding the mechanisms of action ofIUDs in humans. Classically, the view was that the IUD in humans actedpredominantly after fertilization to prevent implantation, but evidencehas accumulated for some effects before fertilization. As a generalrule, the pre-fertilization effects are not enough to preventfertilization and, therefore, the post-fertilization effects are mostimportant. The post-fertilization mechanisms of action of the IUDinclude slowing or speeding the transport of the early embryo throughthe fallopian tube, damage to or destruction of the early embryo beforeit reaches the uterus, and prevention of implantation. This mechanism ofaction is perceived as an early abortion by some, and prevents manypatients from using IUDs as a temporary mode of contraception. Anotherproblem with IUDs is expulsion from the uterus and subsequent unwantedpregnancy. Other potential complications of IUDs are uterine infection,uterine perforation and most important ectopic pregnancy. Ectopicpregnancy is a condition where the embryo has implanted outside of theuterine cavity, usually in the fallopian tube. This condition is alsohazardous to the patient and can lead to internal bleeding and severemorbidity and even mortality. This potential complication also deterspatients from the use of IUDs.

With the foregoing in mind, a need exists for an improved intrauterinesystem replacing currently marketed IUDs and other methods ofcontraception, such as, tubal ligation.

SUMMARY OF THE INVENTION

It is, therefore, an object of the present invention to provide anintrauterine device for applying pressure to the walls of the uterinecavity including a resilient body having an elongated member whichincludes a first end and a second end which are resiliently biased awayfrom each other. The first end of the elongated member includes a firstleg having a first end and a second end. The second end of the elongatedmember includes a second leg having a first end and a second end. Aconnection member is positioned between the first end of the first legand the first end of the second leg. A first plug member is secured atthe second end of the first leg and a second plug member is secured atthe first end of the second leg. The first and second plug members areshaped and dimensioned for bearing against the walls of the uterinecavity as the elongated member spreads outwardly with the first end andthe second end moving apart.

It is also an object of the present invention to provide a method forpreventing conception within the uterine cavity including the step ofdelivering an intrauterine device into the uterine cavity. Theintrauterine device includes an elongated member with a first end andsecond end. A first plug member is secured at the first end of theelongated member and a second plug member is secured at the second endof the elongated member. The method further includes causing theintrauterine device to apply pressure within the uterine cavity in amanner that will alter the shape of the uterine cavity over time thuspreventing conception.

It is another object of the present invention to provide a method fordelivering an intrauterine device including the steps of advancing theintrauterine device into the uterine cavity. The intrauterine deviceincludes an elongated member with a first end and second end, and afirst plug member secured at the first end of the elongated member and asecond plug member secured at the second end of the elongated member.The method further includes releasing the intrauterine device. Releaseresults in (a) the first and second plug members first moving outwardlydue to stored outward bias in the elongated member, (b) the first andsecond plug members then moving upwardly within the uterine cavity, (c)the first and second plug members then moving into contact withrespective opposed walls of the uterine cavity and (d) the first andsecond plug members applying pressure to respective opposed walls of theuterine cavity to prevent conception within the uterine cavity.

It is a further object of the present invention to provide a method forpreventing conception within the uterine cavity including the step ofdelivering an intrauterine device into the uterine cavity forpositioning between lateral walls of the uterine cavity. Theintrauterine device includes an elongated member with a first end andsecond end, and a first plug member secured at the first end of theelongated member and a second plug member secured at the second end ofthe elongated member. The method also includes the step of causing theintrauterine device to expand within the uterine cavity such that adistance between the first plug member and the second plug member isgreater than the distance between opposed lateral walls of the uterinecavity.

Other objects and advantages of the present invention will becomeapparent from the following detailed description when viewed inconjunction with the accompanying drawings, which set forth certainembodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1 to 6 are various views showing delivery of the intrauterinedevice in accordance with a preferred embodiment of the presentinvention.

FIGS. 7A to 7D are detailed views showing the delivery apparatus for usein accordance with a preferred embodiment of the present invention withthe steps of forcing the intrauterine device from within a container viaa delivery rod.

FIGS. 8 to 13 are various views showing retrieval of the intrauterinedevice shown with reference to FIG. 1, while FIG. 8A shows an alternateembodiment in accordance with the present invention.

FIGS. 14 and 15 are schematics showing an alternate embodiment of theintrauterine device wherein the plug members ride on the first andsecond legs for sliding movement of the plug members relative to therespective first and second legs.

FIGS. 16A, 16B, 16C and 16D show various shapes of an elongated memberthat may be used in accordance with the present invention.

FIGS. 17, 18 and 19 show alternate embodiments of a connection member inaccordance with the present invention.

FIGS. 20A-K show other connection member structures in accordance withthe present invention.

FIGS. 21-25 show alternate embodiments employing a substantiallystraight elongated member.

FIGS. 26A, 26B and 26C show an alternate structure for an intrauterinedevice in accordance with the present invention.

FIG. 27 shows yet another structure for an intrauterine device inaccordance with the present invention.

FIG. 28 is a cross sectional view of a plug member in accordance with apreferred embodiment of the present invention.

FIGS. 29, 30, 31 and 32 show the steps associated with varioustechniques for the application of a tissue in-growth member to the plugmember.

FIGS. 33 and 34 show plug members specifically designed for encouragingtissue in-growth.

FIGS. 35 and 36 are top plan views showing alternate plug member shapesin accordance with the present invention.

FIGS. 37, 38, 39, 40, 41, 42 and 43 are schematic views of alternateembodiments of a plug member and/or elongated member structure inaccordance with the present invention.

FIG. 44 is a schematic view of an alternate embodiment of anintrauterine device in accordance with the present invention.

FIG. 45 is a graph showing load profiles for the resilient body inaccordance with the present invention.

FIG. 46 is a schematic demonstrating movement of the plug members duringdeployment of the intrauterine device shown with reference to FIGS.1-13.

FIG. 47 is a schematic of an alternate embodiment in accordance with thepresent invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The detailed embodiments of the present invention are disclosed herein.It should be understood, however, that the disclosed embodiments aremerely exemplary of the invention, which may be embodied in variousforms. Therefore, the details disclosed herein are not to be interpretedas limiting, but merely as the basis for the claims and as a basis forteaching one skilled in the art how to make and/or use the invention.Since various embodiments are disclosed herein, similar referencenumerals have been employed throughout the present disclosure whenreferring to similar elements in the various embodiments and where suchuse of similar references numerals is deemed appropriate.

With reference to the various figures, an intrauterine device 10 inaccordance with a preferred embodiment of the present invention isdisclosed that will actively bear against the lateral walls 15 a of theuterine cavity 16 using the shape of the uterine cavity 16 as a guide tothe proper positioning of the intrauterine device 10. The presentintrauterine device 10 allows safe contraception without the use ofhormones. As will be appreciated based upon the following disclosure,the present intrauterine device 10 is flexible and, in accordance with apreferred embodiment, is made from a Nitinol resilient body 18 and two 3mm POREX, a porous polyethylene manufactured by Porex Technologies, plugmembers 20, 22. The use of Nitinol in the construction of the resilientbody 18 facilitates gentle and constant pressure on the lateral uterinewalls 15 a. The Nitinol offers a unique property of constant lateralpressure in various uterine sizes. Because of this reason, the presentintrauterine device 10 is “one size fits all”. Constant gentle lateralpressure along the lateral walls 15 a of the uterine cavity 16 preventsexpulsion as the intrauterine device 10 is always situated in the upperpart of the uterine cavity 16. When properly positioned, the plugmembers 20, 22 are within centimeters of the respective orifices 12 ofthe fallopian tubes 14, at a position beneath the orifices 12 and alongthe lateral walls 15 a of the uterine cavity 16; preferably at aposition within 1 cm inferior to the orifices 12 of the fallopian tubes14. The plug members 20, 22 are consistently situated in the vicinity ofthe fallopian tube orifices 12. The plug members 20, 22 offer a largercontact point with the lateral walls 15 a of uterine cavity 16 makingperforation and discomfort unlikely. This was proven in the clinicalsetting. The intrauterine device 10 sits in the uterus and exerts somelateral pressure which slightly distorts the uterine cavity 16. Inaccordance with a preferred embodiment, the pressure applied is at leastapproximately 0.01 ft·lb, more preferably between approximately 0.01ft·lb and approximately 0.025 ft·lb. This gentle distortion likelydisturbs uterine contraction and possibly further assists theintrauterine device 10 in preventing intrauterine pregnancy. Thiscombined action of foreign body and gentle pressure of the lateral walls15 a of the uterus likely explains the excellent clinical results withthe present intrauterine device 10. The gentle constant lateral pressurewith the present intrauterine device 10 makes the device completely painfree to women and offers the advantage of pain free insertion andplacement compared to other stiffer IUDs.

With the foregoing in mind, and as will be discussed below with regardto tissue in-growth, control of the applied force is important becausethe applied force, or pressure, causes distortion of the lateral walls15 a of the uterine cavity 16. With this in mind, the deployedintrauterine device 10 is designed to apply sufficient pressure toslightly distort the uterine cavity 16 preventing conception. Moreparticularly, testing has revealed the plug members must preferably spana distance of approximately 18 mm to approximately 54 mm depending uponthe anatomical characteristics of the patient. The elongated member(regardless of the embodiment as described herein) is, therefore,capable of moving (for example, spreading based upon the inherent springbias) to spread the first and second plug members from betweenapproximately 18 mm and 54 mm apart. The present intrauterine device, inparticular, the elongated member, must further be capable of applying arelatively consistent force (for example, a load of at leastapproximately 0.01 ft·lb in accordance with a preferred embodiment)while the plug members are positioned within the desired span betweenthe lateral walls 15 a of the uterine cavity 16. In accordance with apreferred embodiment, the load is approximately 0.01 ft·lb toapproximately 0.025 ft·lb. Each of the embodiments disclosed hereinattempts to accommodate these requirements with the controlledapplication of force. For example, the embodiment described withreference to FIGS. 1 to 6 is preferably manufactured from Nitinol whichhas been found capable of providing relatively consistent application offorce across a wide range of plug member spans (see FIG. 45 showing theload profiles for Nitinol at various rod thicknesses). Irritation(and/or damage) encouraging tissue in-growth may be further facilitatedby applying corrosive material to the surface of the plug member.

With the foregoing in mind, the distance between the first and secondplug members 20, 22 when the intrauterine device 10 is fully extendedmust be greater than the distance between the lateral walls 15 a of theuterine cavity adjacent the fallopian tube orifices 12 when the uterinecavity is in its relaxed state. It should be appreciated that it hasbeen determined the average intra-ostial distance in nulliparous womenis 29.2 mm and the average intra-ostial distance in parous women is 30.0mm. “Assessment Of The Uterine Cavity And The Intraostial Distance UsingHysterosalpingography”, Fertility and Sterility, Volume 88, Supplement1, September 2007, Page S202, J. G. Bromer, F. Sanguinetti, M. Tal, P.Patrizio. Obstetrics, Gynecology, and Reproductive Sciences, YaleUniversity School of Medicine, New Haven, Conn.; Department ofRadiology, Yale University School of Medicine, New Haven, Conn.

As will be appreciated based upon the following disclosure, the presentinvention provides a delivery system that is simple to use andintuitive. The size of the delivery system is very small and allowsinsertion without pre dilatation, pain or use of local anesthesia.Insertion by the gynecologist is blinded and placement is consistentlyreliable. The present intrauterine device 10 is very well seen ontransvaginal ultrasound. The plug member 20, 22 are well visualized andechogenic. The location of the plug members 20, 22 in the lateral partof the uterus is consistently seen on ultrasound. It is contemplated thepresent intrauterine device 10 can have copper on it. In this case, thecopper can be placed in the vicinity of the plug members 20, 22 and bedelivered in the vicinity of the fallopian tubes 14, making thelikelihood of ectopic pregnancy even less likely.

The shape of the uterine cavity 16 is illustrated in FIG. 1. The uterinecavity 16 is normally in continuation with the fallopian tubes 14. Forfertilization, the sperm migrates from the uterine cavity 16 into thefallopian tube 14. The force applied by the intrauterine device 10 inbearing against the lateral walls 15 a of the uterine cavity 16 preventsfertilization. For successful pregnancy, a normal uterine environment isneeded as well as normal uterine contractions. The pressure on thelateral walls 15 a of the uterine cavity 16 distorts normal uterinecontractions and further reduces the likelihood of pregnancy, thusimproving the effectiveness of the present intrauterine device 10.

The present invention provides an intrauterine device 10 that is eitherpermanent, removably permanent or temporary, in part or wholly,utilizing the unique shape of the uterine cavity 16. The presentinvention also allows nonsurgical contraception that can be done as anoffice procedure and without the need for surgery or the necessity forvisualization either radiologically, ultrasonically, or with ahysteroscope. The present intrauterine device 10 uses radial force andinherent properties in its construction to prevent migration orexpulsion of the intrauterine device 10. As such, the present inventionmay be used with the following procedures: contraception, eitherpermanent or temporary; and potential treatment of other causes ofabnormal uterine bleeding or pelvic pain. The present intrauterinedevice 10 may be adaptable to other therapies or treatments, such aslocalized medicinal delivery, with only an alteration to the barriersystem.

As briefly discussed above, the present invention provides a method andapparatus for preventing conception wherein two plug members 20, 22 bearagainst the lateral walls 15 a of the uterine cavity 16 by spreadingthem as far apart as the anatomy of the uterus permits and allowing thepressure generated as a result of spreading to be applied to the lateralwalls 15 a of the uterine cavity 16. For example, and as will beappreciated based upon the following disclosures, various structures maybe employed in creating the necessary pressure. In accordance withvarious preferred embodiments described herein, the length between theplug members 20, 22 is adjusted by flexion of the elongated member 18 ofthe intrauterine device 10. As will be appreciated by the followingdisclosures, it is not necessary that the intrauterine device 10 relyupon spring-like or resilient structures to achieve the creation ofpressure but may employ other mechanical features as described herein.

In accordance with a preferred embodiment, the unique shape of theuterine cavity 16 allows the present intrauterine device 10 to beinserted without (or with) visualization into the uterine cavity 16 forpositioning in a manner that bears against the lateral walls 15 a of theuterine cavity 16. The unique shape also maintains the intrauterinedevice 10 in place without the need for sutures or any other anchoringmechanism. The present intrauterine device 10 is also readily removable.The presence of the intrauterine device 10 in the uterine cavity 16 actsas an IUD by preventing fertilization and thereby averts the destructionof an embryo, which is considered the major mechanism of an IUD's birthcontrol efficacy. This makes the present intrauterine device 10 moreacceptable to some patients and allows its use in a larger part of thepopulation.

As mentioned above, the present intrauterine device 10 functionsprimarily as an IUD. The present invention also relates to a method andapparatus for transvaginal implantation and removal of the intrauterinedevice 10.

As discussed below in greater detail, the present intrauterine device 10is composed of a resilient body 18 with first and second plug members20, 22 at the respective first and second ends 24, 26 of the resilientbody 18. The resilient body 18 is preferably made from a shape memoryalloy metal (such as, Nitinol) or any other material (or combination ofmaterials) that will create an appropriate load providing an appropriatelateral force as the intrauterine device 10 is deployed within theuterine cavity 16. The outwardly directed lateral force generated by theresilient body 18 brings the first and second plug members 20, 22 intocontact with the lateral walls 15 a of the uterine cavity 16 creatingopposed force along the lateral walls 15 a of the uterine cavity 16 andcausing the intrauterine device 10 to ride up the lateral walls 15 a ofthe uterine cavity 16 until the first and second plug members 20, 22seat along the lateral walls 15 a of the uterine cavity 16 bearingagainst the walls 15 a thereof at a position adjacent the orifices 12 ofthe fallopian tubes 14; preferably at a position within 1 cm inferior tothe orifices 12 of the fallopian tubes 14. It should also be noted theplug members of the intrauterine device 10 might simply be initiallyapplied at the location where pressure is to be applied and not ride upthe lateral walls. It has further been found the plug members 20, 22move laterally indenting the contour of the uterine cavity 16 afterplacement. It is also contemplated the resilient body could be made outof resorbable magnesium alloy wire or resorbable plastic.

Although Porex porous polyethylene is disclosed above as a preferredmaterial for use in the construction of the plug members 20, 22, theplug members 20, 22 can be made from various materials such as metals,plastics, elastomers such as silicone, or combinations thereof, and beimpregnated with various medications and compounds. As will beappreciated based upon the following disclosure, it is furthercontemplated the material composition of the plug members 20, 22 couldbe selected such that it would encourage tissue in-growth or prevent (orminimize) tissue in-growth, therefore controlling the ease of removal ofthe intrauterine device 10 after the passage of time. When tissuein-growth is desired, molded materials such as specially processedporous silicone, polyethylene, polypropylene, etc. could be used in themanufacture of the plug members 20, 22 to allow tissue in-growth. Inaddition to generally molded constructions, the plug members 20, 22 maytake the form of a mesh or coil with or without a tissue in-growthmember (for example, of a mesh material) for anchoring to surroundingtissue. The resilient body 18 and/or plug members 20, 22 can be eitherinert, meaning without any medication or substance on them, or releasedfrom them, or they can be impregnated or coated, in part or wholly, withany medication such as hormones or metal, such as, copper. The plugmembers 20, 22 can also be covered with any other kind of spermicide orother materials. As a result, the present intrauterine device 10 may beused as a medication delivery device, supplying medication to specificlocations and then retrieved in part or wholly as discussed below withreference to FIGS. 8-13.

The intrauterine device 10 utilizes the shape of the uterine cavity 16and conforms the shape of the first and second plug members 20, 22 tothe lateral walls 15 a of the uterine cavity 16, and/or the plug members20, 22 elastically or deformably conform to the lateral walls 15 a ofthe uterine cavity 16. As briefly mentioned above, the plug members 20,22 can contain any kind of material or medicine to be delivered to thelateral walls 15 a of the uterine cavity 16. Once the material ormedicine is delivered, the intrauterine device 10 can be removed in themanner discussed below with reference to FIGS. 8 to 13.

Referring to the various figures, and in accordance with a preferredembodiment of the present invention, the present intrauterine device 10includes a resilient body 18 exhibiting spring-like characteristics. Theresilient body 18 has first and second plug members 20, 22 secured atopposite ends thereof. In accordance with a preferred embodiment of thepresent invention, the first and second plug members 20, 22 are shapedand dimensioned to ride up the lateral walls 15 a of the uterine cavity16 until they seat along the lateral walls 15 a of the uterine cavity 16at a position adjacent the orifices 12 of the fallopian tubes 14 as theresilient body 18 spreads outwardly with the first end 24 and second end26 thereof moving apart and bearing upon the lateral walls 15 a of theuterine cavity 16 in a manner preventing conception. Optimal bearingpressure has been found to be achieved when the plug members 20, 22 havea diameter from approximately 1 mm to 8 mm, more preferably 3 mm. Thisoptimal plug member also allows delivery through a small delivery systemthat is convenient and pain free to the patients. This size of plugmember also minimized the risk of uterine perforation, a well known riskof currently available intrauterine devices.

More particularly, the resilient body 18 includes an elongated member 28having a first end 30 and a second end 32. The first end 30 of theelongated member 28 is composed of a first leg 34 and the second end 32of the elongated member 28 is composed of a second leg 36. The firstplug member 20 is secured at the distal end of the first end 30 of theelongated member 28 and the second plug member 22 is secured at a distalend of the second end 32 of the elongated member 28.

The first leg 34 includes a first end 38 and second end 40, and thesecond leg 36 includes a first end 42 and second end 44. The first ends38, 42 of the respective first and second legs 34, 36 are respectivelyconnected, while the second ends 40, 44 of the first and second legs 34,36 are respectively free and are provided with, and coupled to, therespective first and second plug members 20, 22. A connection member 37resiliently (or rigidly) couples the first ends 38, 42 of the first andsecond legs 34, 36 in a manner biasing the second ends 40, 44 of thefirst and second legs 34, 36 from each other when they are notrestrained in a manner discussed below in greater detail.

With this in mind, the first leg 34 and the second leg 36 are angularlyoriented relative to each other creating an elongated member 28 which issubstantially V-shaped when the first leg 34 and the second leg 36 areallowed to move away from each other based upon the outward biasinherent in the connection member 37 between the first and second legs34, 36. The inherent bias in the connection member 37 is created throughthe utilization of spring materials or shape memory materials in theconstruction of the resilient body 18, in particular, the connectionmember 37. With this in mind, the connection member 37 includes asubstantially circular configuration with a first end 37 a connected tothe first end 38 of the first leg 34 and a second end 37 b connected tothe first end 42 of the second leg 36 (see FIGS. 7C and 7D). Theconnection member 37 is formed with an inherent outward bias that forcesthe first leg 34 and the second leg 36 outwardly upon deployment.

In addition, and in accordance with a preferred embodiment, the firstleg 34 and the second leg 36 are formed with an outward bow when fullyextended. This outward bow can store further outward bias when theintrauterine device 10 is compressed for storage and deployment. Inaccordance with a preferred embodiment, when the intrauterine device 10is entirely unrestrained the first and second legs 34, 36 will form amaximum open angle of approximately 150 degrees or other appropriateangular dimension so as to adequately contribute to the aforementionedoutward bias. This angle forms a geometry preventing the first andsecond legs 34, 36 from moving away from a fundamentally centralizedlocation in the uterine cavity 16 (see FIGS. 1 to 6). That is, the shapeof the resilient body 18, a sort of triangle, only spreads so wide sothat it would bump into the lateral walls 15 a of the uterine cavity 16,that way staying located in the center of the uterine cavity 16.

The combination of the outwardly bowed first and second legs 34, 36 andthe connection member 37 allows for the creation of an outwardlydirected load providing an appropriate lateral force to bring the firstand second plug members 20, 22 into contact with the lateral walls 15 aof the uterine cavity 16 causing the intrauterine device 10 to ride upthe lateral walls 15 a of the uterine cavity 16 until the first andsecond plug members 20, 22 seat along the lateral walls 15 a of theuterine cavity 16 at a position adjacent the orifices 12 of thefallopian tubes 14 biasing the lateral walls 15 a of the uterine cavity16 outwardly in a manner preventing conception. As such, and asdiscussed herein in greater detail, the present intrauterine device 10may be delivered by release within the uterine cavity 16 with automaticexpansion resulting in controlled, self-positioning of the respectiveplug members 20, 22 along the lateral walls 15 a of the uterine cavity16.

Referring to FIGS. 14 and 15, an alternate embodiment in accordance withthe present invention is disclosed. In accordance with this embodiment,the plug members 20, 22 are designed to slide along the resilient body18. In particular, the resilient body 18 is once again made from a shapememory alloy metal, or other appropriate resilient material, and isformed in the shape of a V such that the first and second ends 24, 26 ofthe resilient body 18 are directed toward the lateral walls 15 a of theuterine cavity 16 when properly inserted within the uterine cavity 16.However, upon insertion, the plug members 20, 22 are located at a firstposition adjacent the connection member 37 linking the first and secondlegs 34, 36 (see FIG. 14). Once the resilient body 18 is positionedwithin the uterine cavity 16 with the second ends 40, 44 of therespective first and second legs 34, 36, that is, the first and secondends 24, 26 of the resilient body 18, positioned and seated along thelateral walls 15 a of the uterine cavity 16 applying outward pressurethereto, the plug members 20, 22 are respectively moved upwardly alongthe first and second legs 34, 36 to a second position adjacent thesecond ends 40, 44 of the respective first and second legs 34, 36 wherethe plug members 20, 22 are positioned along the lateral walls 15 a ofthe uterine cavity 16. With this in mind, each of the first and secondplug members 20, 22 is formed with a central bearing aperture 308through which the resilient body 18 passes during usage. Retention ofthe plug members 20, 22 at the second ends 40, 44 of the first andsecond legs 34, 36 is achieved by frictional retention due to theinteraction between the central bearing apertures 308 and enlarged,spherical member 309 formed at the second ends 40, 44 of the respectivefirst and second legs 34, 36.

Although a preferred embodiment of the present invention employs aV-shaped elongated member with an outward bow as disclosed above, it iscontemplated the elongated member 28 may be formed with a variety ofshapes (whether in a fundamentally two dimensional planar configurationor a three dimensional planar configuration) so long as it retains itsspring-like properties. Examples of contemplated shapes are shown inFIGS. 16A to 16D: FIG. 16A shows a U-shaped elongated member; FIG. 16Bshows a stepped elongated member; FIG. 16C shows a crescent-shapedelongated member; and FIG. 16D shows a chevron-shaped elongated member.

In addition, the spring bias may be imparted to the first leg 34 and thesecond leg 36 by constructing the connection member 37 with a springbiased loop 39 as shown in FIG. 17 or the spring bias may be controlledby incorporating bends 60 in the connection member 37 as shown in FIG.18.

In accordance with yet another embodiment and as shown in FIG. 19, abiased loop 39 composed of multiple windings may also be employed.Similarly, and with reference to FIGS. 20A-20K, the biased loops 39 maytake a variety of configurations designed to achieve a desired biasalong the length of the first and second legs 34, 36. Ultimately, thebias of the connection member may be varied to suit the specific needsof the user.

Considering the various shapes that may be employed in accordance with apreferred embodiment of the present invention, it is contemplated theoutward bias of the first and second legs may be achieved by creatingresilience along the length of the first and second legs rather than atthe connection point of the first and second legs. For example, wherethe first and second legs are formed of Nitinol, the first and secondlegs may be formed such that they bow outwardly when exposed to elevatedactivation temperature upon placement within the body.

With regard to the material construction of the elongated member 28, andfurther to the earlier disclosure, it is preferably composed ofresilient, biocompatible materials (metal, polymer or composite) orshape memory or super-elastic materials (for example, Nitinol), otheralloys, or combinations thereof, capable of offering the biasingcharacteristics discussed herein and required for proper operation ofthe present invention. If a material desired for use is notbiocompatible, it could be covered by another biocompatible material,for example, a coating or a thin-walled plastic tube.

Further to the various shapes in which the elongated member 28 may beformed as disclosed above, other shapes are shown with reference toFIGS. 21 to 25. In accordance with these various embodiments, theelongated member 28 could be normally straight when unbiased andpositioned within the uterine cavity 16. In accordance with thisembodiment, the elongated member 28 would be forcibly folded inside thedelivery container 48 (as discussed below in greater detail). Theelongated member 28 is folded in this configuration until such a timethat it is introduced within the uterine cavity 16 and released forpositioning in a manner biasing the lateral walls 15 a of the uterinecavity 16 outwardly. Upon deployment, the elongated member 28 extends toan angular configuration with the plug members 20, 22 positioned alongthe lateral walls 15 a of the uterine cavity 16. It should beappreciated the angle is variable, and depends on the size of theuterus. The angle is usually around 90 degrees or so, but variessignificantly.

Referring to FIGS. 21 and 23-25, the elongated member 28 could be formedwith a U-shaped connection member 37. The connection member 37 is shapedand dimensioned for facilitating the folding and positioning of theelongated member 28 within the delivery container 48 for subsequentexpansion thereof when the elongated member 28 is released duringapplication within the uterine cavity 16. The connection member 37 alsoallows for control of the resilience imparted to the elongated member 28in accordance with desired parameters. FIG. 22 shows an embodimentwherein the connection member 37 is continuous with the elongatedmember.

As discussed above, other mechanical mechanisms for the application ofthe plug members to the walls 15 a of the uterine cavity 16 arecontemplated. For example, mechanical force generating structures may beemployed within the spirit of the invention. With this in mind, and withreference to FIGS. 26A, 26B and 26C, the intrauterine device 410includes an elongated member 428 composed of first and second legs 434,436 connected to each other for controlled relative movement by aclamping member 450. More particularly, the intrauterine device 410 iscomposed of first and second legs 434, 436, each of the first and secondlegs 434, 436 includes a first end 438, 442 and a second end 440, 444wherein an plug member 420, 422 is secured to the respective second ends440, 444 of the first and second legs 434, 436 and the respective firstends 438, 442 are secured via the clamping member 450.

The clamping member 450 is a generally elongated member including firstand second apertures 452, 454 shaped and dimensioned for receiving therespective first ends 438, 442 of the first and second legs 434, 436.Until the clamping member 450 is crimped to lock the first and secondlegs 434, 436 in position relative to the clamping member 450 (as willbe discussed below in greater detail), the apertures 452, 454 are formedto permit relative movement of the first and second legs 434, 436, andultimately, the first and second plug members 420, 422, as the first andsecond legs 434, 436 are moved within the clamping member 450. As willbe appreciated based upon the figures, the first and second legs 434,436 are formed from slightly flexible materials allowing for bendingthereof so as to conform to the anatomical distinctiveness of eachindividual patient.

In accordance with a preferred embodiment, deployment of theintrauterine device 410 is facilitated through the utilization of adeployment assembly 510 as shown with reference to FIG. 26C. Thedeployment assembly 510 includes first and second members 512, 514 whichare resiliently biased outwardly to engage and force the plug members420, 422 into the walls of the uterine cavity 16. The deploymentassembly 510 is further provided with a force gauge 516 for measuringthe applied pressure as the plug members 420, 422 are forced outwardlyinto contact with the lateral walls 15 a of the uterine cavity 16.Alternatively, the deployment assembly could be equipped with a forceindicator such as a colored slide that moves to another position whenappropriate pressure is achieved.

In practice, the intrauterine device 410 is delivered to the uterinecavity 16 and roughly positioned in the upper part of the uterine cavity16 and deployed there. It then uses the shape of the uterine cavity 16as a guide and positions itself in the uterine cavity 16 such that theplug members 420, 422 push slightly against the uterine walls 15 a at aposition adjacent the orifices 12 of the fallopian tubes 14 distortingit over time. In practice it has been found that complete migration anddistortion is achieved over a period of a few weeks. The deploymentassembly 510 is then employed to push the first and second plug members420, 422 into contact with the lateral walls 15 a of the uterine cavity16. When a desired application pressure is achieved, the clamp member450 is crimped in a manner securing it to the first ends 438, 442 of therespective first and second legs 434, 436 thereby locking the first andsecond legs 434, 436 in position relative to each other. Crimping of theclamping member 450 is achieved through utilization of medical gradeforceps shaped and dimensioned to access the uterine cavity 16 andengage the clamping member 450.

In accordance with another embodiment as shown with reference to FIG.27, an elongated member 428 composed of first and second legs 434, 436is similarly provided. The first and second legs 434, 436 respectivelyinclude first and second plug members 420, 422 secured to the secondends 440, 444 thereof. The first ends of the first and second legs 434,436 are structured for a telescopic mating relationship. In particular,the first end 438 of the first leg 434 includes a central threadedpassageway 460 shaped and dimensioned for receiving the first end 442 ofthe second leg 436 in a threaded mating configuration. With this inmind, the internal cavity of the central threaded passageway 460 of thefirst leg 434 includes threading 462 shaped and dimensioned to mate andengage threading 464 formed along the external surface of the second leg436. As such, rotation of the first and second legs 434, 436 relative toeach other alters the effective length of the intrauterine device 410 bymoving the first and second plug members 420, 422 further apart.

In practice, the intrauterine device 410 is delivered to the uterinecavity 16 and roughly positioned in the upper part of the uterine cavity16 and deployed there. It then uses the shape of the uterine cavity 16as a guide and positions itself in the uterine cavity 16 such that theplug members 420, 422 push slightly against the uterine wall 15 adistorting it over time. In practice it has been found that completemigration and distortion is achieved over a period of a few weeks. Thefirst and second legs 434, 436 are then engaged and rotated, pushing thefirst and second plug members 420, 422 outwardly into contact with thelateral walls 15 a of the uterine cavity 16. When a desired applicationpressure is achieved, rotation is terminated thereby locking the firstand second legs 434, 436 in position relative to each other with theplug members 420, 422 positioned such that they apply outward pressureto the lateral walls 15 a of the uterine cavity 16.

As shown with reference to FIGS. 3-6, 7A-D and 8-11, and in accordancewith a preferred embodiment, the plug members 20, 22 are spherical. Inaccordance with a preferred embodiment, the plug body 23 of the plugmember 20, 22 is made of silicone or porous, high density polyethyleneexhibiting structure permitting tissue in-growth. Depending upon whetherit is desired to provide a retrievable plug member 20, 22 or apermanently anchored plug member 20, 22, the outer surface 25 of theplug member 20, 22 will either be the silicone from which it is made (inwhich case the plug body 23 forms substantially all of the plug member20, 22 as shown in FIGS. 3-6, 7A-D and 8-11), be composed of a tissuein-growth member 62, for example, porous, high density polyethylene,which is secured about the outer surface 27 of the silicone plug body(or substrate) 23 (see FIG. 28 which is discussed below in greaterdetail), or be composed of a foamed silicone with interstitial voids.

Where a permanent anchoring of the plug member 20 is desired, and withreference to an embodiment of the present invention as disclosed withreference to FIG. 28, a tissue in-growth member 62 is positioned overthe silicone substrate material making up the plug body 23 so as toprovide the plug member 20, 22 with an outer tissue in-growth surface27. Although reference numeral 20 is used in describing the plug memberit will be understood the first and second plug members 20, 22 areidentical and/or symmetric. However, it is contemplated it may beadvantageous to provide for an asymmetric construction with the firstand second plugs differing in construction.

The tissue in-growth member 62 is constructed of a material promotingand maintaining tissue in-growth for the purpose of anchoring the plugmember 20 and/or creating a seal. It is contemplated the tissuein-growth member 62 could be a biocompatible fabric (for example, apolyester fabric), textile, felt or membrane known by those skilled inthe art to encourage tissue in-growth. In accordance with a preferredembodiment of the present invention, it is contemplated the tissuein-growth member 62 may be a knitted polymer textile with appropriatetissue in-growth properties to be considered an acceptable option foruse in conjunction with the present invention. The tissue in-growthmember could further be covered with a specialty coating that enhancesand/or accelerates tissue in-growth.

The tissue in-growth member 62, which is also referred to as a “fabricsock” in accordance with the embodiments described below, may be securedto the plug body 23 through the implementation of various techniques.For example, and with reference to FIG. 29, a cylindrical fabric sock 62with open ends is placed over the plug body 23 and the fabric sock 62 istwisted so as to create a reduced diameter by twisting or knotting,section 64 distal of the plug body 23. Thereafter, the distal portion 66of the fabric sock 62 is pulled proximally and over the reduced diametertwisted section 64 and the plug body 23. A band 68 is then applied tothe fabric sock 62 proximally of the plug body 23 to secure it inposition about the plug body 23.

In accordance with an alternate embodiment, and with reference to FIG.30, a fabric sock 62 with a closed distal end 70 is pulled over the plugbody 23. The closed distal end 70 is preferably formed through theapplication of heat to close the distal end 70 of the fabric sock 62.Once the fabric sock 62 is pulled over the plug body 23 with the closeddistal end 70 of the fabric sock 62 covering the distal end of the plugbody 23, the proximal end 72 of the fabric sock 62 is closed via theapplication of a band 68 proximally of the plug body 23 to secure it inposition about the plug body 23.

In accordance with yet another embodiment, and with reference to FIG.31, a cylindrical fabric sock 62 with open ends may be formed into adouble layered, closed ended fabric sock 62 by tying the center 74 ofthe cylindrical fabric sock 62 and pulling one end 76 thereof over theother end 78 resulting in a fabric sock 62 with a closed distal end 70.Thereafter, the fabric sock 62 is pulled over the plug body 23 with theclosed distal end 70 of the fabric sock 62 covering the distal end ofthe plug body 23, the proximal end of the fabric sock 62 is closed viathe application of a band 68 proximally of the plug body 23 to secure itin position about the plug body 23. The embodiment disclosed above withreference to FIG. 32 may be varied by utilizing a washer 80 to constrictthe center of the cylindrical fabric sock 62 as opposed to the tiedisclosed above.

With reference to FIGS. 33 and 34, plug members with various in-growthpromoting construction are disclosed. In accordance with FIG. 33, theplug member 20 is provided with grooves 81 to promote tissue in-growth.Such a concept might utilize plug members which are round, spherical,square, etc. In accordance with another embodiment as shown withreference to FIG. 34, the plug member 20 is provided with a spike orbarb 81 designed to promote tissue in-growth.

Although a spherical plug member is disclosed above in accordance with apreferred embodiment, those skilled in the art will appreciate othershapes may be used without departing from the spirit of the presentinvention. Although reference numeral 20 is used in describing the plugmember, it will be understood the first and second plug members 20, 22are identical. In accordance with a first alternate embodiment, and withreference to FIG. 35, the plug member 20 takes the form of a “flyingsaucer”. As such, the plug member 20 includes an upper conical surface82 with a domed tip, a central portion 84, and a lower conical surface86 with a domed tip. More particularly, the upper conical surface 82 issubstantially cone-shaped with a concave wall and extends from a roundedcrown section 88 to a wider base section 90 which transitions into thecentral portion 84. The central portion 84 is substantially circular incross section with a convex wall and extends from a smaller top radiusportion to a large central radius portion and back to a smaller bottomradius portion. Beneath the central portion 84 is the lower conicalsurface 86 that is a mirror image of the upper conical surface 82 and,therefore, extends from a relatively large radius base section 92 to arounded crown section 94 at its lowest extent.

Referring to FIG. 36, a plug member 20 with a football shape isdisclosed. This shape includes a convex outer wall and a circular crosssection when viewed in a plane perpendicular to the longitudinal axis ofthe plug member 20 that goes from a relatively small radius first tipmember 96 to a large radius central section 98 and back to a smallradius second tip member 100.

Further, and with reference to FIG. 37, a ball and socket arrangementfor a plug member 20 is disclosed. In accordance with such anembodiment, the plug member 20 is designed with a leading end 180 havinga guiding nose 182 shaped and dimensioned to find the appropriatelocation along the wall of the uterine cavity 16. Articulation of theplug member 20 is achieved by coupling the plug member 184 to the first(and second) leg 34 via a ball joint 186. The ball and socket joint ofthis embodiment would provide the plug member 20 with a degree offreedom to swivel and angularly align with the walls 15 a of the uterinecavity 16 creating a more even distribution of force.

In accordance with an alternate embodiment, and with reference to FIGS.38 and 39, a flexibility similar to the ball and socket arrangement maybe achieved by reducing the cross sectional area at the second ends 40,44 of the respective first and second legs 34, 36 to achieve a higherflexibility and improved compliance to the uterine cavity shape. As aresult, the second ends 40, 44 at each of the respective first andsecond legs 34, 36 are provided with a reduced diameter section 40 a, 44a allowing for greater flexibility of the elongated member 28 in thearea adjacent the first and second plug members 20, 22.

As discussed above, the plug members are composed of porous polyethylenein accordance with a preferred embodiment. However, and for each of theplug shapes disclosed above, the plug members may be formed in a dualdensity configuration of various biocompatible elastomers. Inparticular, and with reference to FIG. 40, the inner portion 188 of theplug member 20 is made from a relatively hard material and forms afoundation for the plug member 20. Affixed over the inner portion 188 isan outer soft pliable material 190. The soft pliable material 190 formsthe outer surface 191 of the plug member 20.

In accordance with an alternate embodiment, and with reference to FIG.41, the plug member 20 maybe formed with a hard outer shell 192 (forexample, gelatin tablet material) temporarily affixed to the outersurface 27 of the main plug body 23 of the plug member 20 that is madeof a soft pliable material (or a dual density configuration as describedabove) for the purpose of protecting the softer inner material. The hardouter shell 192 behaves like a slippery surface during insertion anddeployment. However, the hard outer shell 192 is composed of abioabsorbable or decomposable (that is, expelled during normal menstrualcycle) material which quickly dissolves upon deployment within theuterine cavity 16. As a result, the hard outer shell 192 dissolves andis discharged or absorbed allowing the soft pliable material of theouter surface 27 to ultimately seat along the lateral walls 15 a of theuterine cavity 16.

As discussed above in accordance with a preferred embodiment, enhancedcoupling of the plug member to the tissue surface is achieved by theapplication of a tissue in-growth member of mesh about the siliconeouter surface of the plug member. However, it is contemplated othertechniques may be employed to achieve desirable coupling of the plugmember along the wall of the uterine cavity. For example, and inaccordance with one embodiment as shown with reference to FIG. 42, theouter surface 25 of the plug member 20 is provided with tissue in-growthpromoting/compatible whiskers 194. The tissue in-growthpromoting/compatible whiskers 194 help to integrate the plug member 20within the anatomy. Similarly, and with reference to FIG. 43, tissuein-growth promoting/compatible loops 196 may be integrated into the plugmember 20 for the same purpose of securing the same to the anatomy.Where such tissue in-growth promoting structures are employed, they maybe composed of bioresorbable or bioabsorbable materials such that theplug members will completely dissolve over a predetermined period oftime or they may simply be composed of tissue in-growth promotingmaterials that will remain stable until such a time the plug members areremoved.

Delivery of the present intrauterine device is achieved in the mannerdescribed with reference to commonly owned PCT Publication No.WO2006/088909, which is based upon International Application No.PCT/US2006/005245, filed Feb. 15, 2006, entitled “INTRAUTERINE FALLOPIANTUBE OCCLUSION DEVICE AND METHOD FOR USE”, which is incorporated hereinby reference. Briefly, and with reference to FIGS. 1 to 6 and 46, theintrauterine device 10 is packaged in a small caliber longitudinaldelivery container 48 which forms part of the delivery apparatus 46.This delivery container 48 is advanced into the uterine cavity 16through the vagina 50 and cervix 52 (FIG. 2 and Points 0 of FIG. 46which show the position of the plug members 20, 22 at this step of thedeployment). Once inside the uterine cavity 16, the intrauterine device10 is partially released and advanced from the delivery container 48 viaa delivery rod 54 extending through the delivery container 48 forpushing the intrauterine device 10 from its storage position within thedelivery container 48, preferably, while pulling the delivery container(or sheath) 48 back so as to prevent damage to the uterus orintrauterine device 10. Upon initial deployment, the plug members 20, 22will first move outwardly due to the stored outward bias in the firstand second legs 34, 36 (see Points 1 of FIG. 46 which show the positionof the plug members 20, 22 at this step of the deployment). As theintrauterine device 10 is further deployed, the plug members 20, 22,move upwardly within the uterine cavity 16 (see Points 2 of FIG. 46which show the position of the plug members 20, 22 at this step of thedeployment). Once the intrauterine device 10 is fully or almost fullyreleased from the delivery container 48 during deployment, with thepresent intrauterine device 10 no longer being contained by the deliverycontainer 48 (with the delivery rod 54 secured thereto in accordancewith a preferred embodiment), the first and second legs 34, 36 and theconnection member 37 bow outwardly allowing the intrauterine device 10to take a shape of a “Y” with the plug members 20, 22 in contact withrespective opposed lateral walls 15 a of the uterine cavity (FIG. 3 andPoints 3 of FIG. 46 which show the position of the plug members 20, 22at this step of the deployment)). As the intrauterine device 10 furtheropens with the first and second legs 34, 36 moving apart and therespective plug members 20, 22 applying pressure to the opposed lateralwalls 15 a of the uterine cavity 16, the plug members 20, 22 of theintrauterine device 10 ride up the opposed lateral walls 15 a of theuterine cavity 16 directing themselves to a seating position along thelateral walls 15 a of the uterine cavity 16 at a position adjacent theorifices 12 of the fallopian tubes 14 were they apply outward pressureto the lateral walls 15 a of the uterine cavity 16 in a mannerpreventing conception (FIG. 4 and Points 4 of FIG. 46 which show theposition of the plug members 20, 22 at this step of the deployment). Atthat point when the intrauterine device 10 can be compressed against thelateral walls 15 a of the uterine cavity 16 it will be released (FIG.5), whether manually or automatically, from the delivery apparatus 46.The delivery apparatus 46 will be removed and the present intrauterinedevice 10 will stay in place (FIG. 6). With the foregoing in mind, thepresent invention provides a device and system for implantationpositioning whereby an appropriate combination of defined deploymentdisplacement and elastic behavior position the implant's plug membersalong the walls of the uterine cavity.

Control of the applied force is important because the applied force, orpressure, causes irritation and encourages subsequent in-growth oftissue within an in-growth encouraging plug member (as disclosed herein)as the plug member contacts the lateral wall of the uterine cavityand/or the orifice of the fallopian tube. With this in mind, thedeployed intrauterine device 10 is designed to apply pressure within theuterine cavity in a manner causing irritation and encouraging tissuein-growth into the first plug member and the second plug member. Moreparticularly, testing has revealed the plug members must preferably spana distance of approximately 18 mm to approximately 54 mm depending uponthe anatomical characteristics of the patient. The elongated member(regardless of the embodiment as described herein) is, therefore,capable of moving (for example, spreading based upon the inherent springbias) to spread the first and second plug members from betweenapproximately 18 mm and 54 mm apart. The present intrauterine device, inparticular, the elongated member, must further be capable of applying arelatively consistent force (for example, a load of approximately 5grams in accordance with a preferred embodiment) while the plug membersare positioned anywhere within the desired span between the lateralwalls of the uterine cavity. In accordance with a preferred embodiment,the load required for the application of the force necessary toencourage in-growth is preferably approximately 5 to 50 grams, and morepreferably 15 to 30 grams, when such a load is applied for a period of 1to 3 months. Each of the embodiments disclosed herein attempts toaccommodate these requirements with the controlled application of force.For example, the embodiment described above with reference to FIGS. 1 to6 is preferably manufactured from Nitinol which has been found capableof providing relatively consistent application of force across a widerange of plug member spans (see FIG. 45 showing the load profiles forNitinol at various rod thicknesses). Irritation (and/or damage)encouraging tissue in-growth may be further facilitated by applyingcorrosive material to the surface of the plug member.

A proposed embodiment for the delivery apparatus 46 is illustrated inFIGS. 7A to 7D. This illustration shows the delivery apparatus 46 withits plug members 20, 22 arranged longitudinally within the deliverycontainer 48. Because of the need to maintain the delivery container 48in the lowest profile possible (the bigger the delivery system the moredilatation of the cervix is needed), the plug members 20, 22 arelocated, staggered, one in front of the other. This also means that thetwo legs 34, 36 of the intrauterine device 10 in this embodiment are aslightly different length. It is contemplated this staggered arrangementmay be achieved by making one leg shorter than the other or by flexingor bending one of the legs to force a corresponding leg to stay behindthe other. Although this embodiment employs a staggered arrangement, itis contemplated the legs may be oriented side by side.

When removal of the intrauterine device 10 is desired, a hook 56, orother removal apparatus that engages the intrauterine device 10, will beadvanced through the vagina 50 and cervix 52 (FIG. 8) and the connectionpoint (for example, a metallic spring) between the plug members 20, 22and the first and second legs 34, 36 will be grasped (FIG. 9). The hook56 will pull on the intrauterine device 10 and insert it into a sheath58 or into the hysteroscope (FIGS. 10, 11, 12). At that stage, thecontained intrauterine device 10 is removed from the uterus and outthrough the cervix 52 and vagina 50 (FIG. 13). This removal would bedone either with or without direct visualization or under fluoroscopicguidance.

In accordance with an alternate embodiment and with reference to FIG.8A, a suture/string loop 49 may be secured to the connection member 37.As such, either the hook 56 or other engagement device may grab thesuture/string loop 49 for retrieval of the intrauterine device.

With reference to FIG. 47, an alternate embodiment of the presentintrauterine device 610 is disclosed. As with the prior embodiments, theintrauterine device 610 includes a resilient body 618 having first,second, third and fourth plug members 620, 622, 624, 626 secured atstrategic positions thereon. The resilient body 618 is shaped anddimensioned to expand in a substantially V-shape as disclosed with theprior embodiments. However, and in contrast to the prior embodiments,the resilient body 618 of the intrauterine device 610 includes resilientfirst and second extension arms 680, 682 respectively extending beyondthe first and second plug members 620, 622, as well as the first andsecond legs 634, 636 for bearing against the upper wall 15 b of theuterine cavity 16. In particular, the first and second extension arms680, 682 are substantially C-shaped with inwardly facing concavesurfaces. Accordingly, and when the first and second plug members 620,622 are positioned against the lateral walls 15 a of the uterine cavity616, the free ends of the extension arms 680, 682 are oriented to bearagainst the upper wall 15 b of the uterine cavity 16.

Enhanced application of pressure to the upper uterine wall 15 b isachieved by providing the free ends of the extension arms 680, 682 withrespective third and fourth plug members 624, 626. As with the priorembodiment, these plug members 624, 626 are substantially spherical andpreferably manufactured from POREX porous polyethylene.

As with the prior embodiments, the first and second legs 636, 638 of theresilient body 618, as well as the first and second extension arms 680,682 exhibit spring like characteristics. With this in mind, theresilient body 618 includes an elongated member 628 having a first end630 and a second end 632. The first end 630 of the elongated member 628is composed of the first leg 634 and first extension arm 680 and thesecond end 632 of the elongated member 628 is composed of the second leg636 and the second extension arm 682. The first plug member 620 issecured at the distal end of the first leg 634 midway along the lengthof the first end 630 of the elongated member 628 and the second plugmember 622 is secured at the distal end of the second leg 636 midwayalong the length of the second end 632 of the elongated member 628.

More particularly, the first leg 634 includes a first end 638 and asecond end 640, and the second leg 636 includes a first end 642 and asecond end 644. The first ends 638, 642 of the respective first andsecond legs 634, 636 are respectively connected, while the second ends640, 644 of the first and second legs 634, 636 are respectively providedwith the respective first and second plug members 620, 622 and coupledto the first and second extension arms 680, 682.

A connection member 637 resiliently couples the first ends 638, 642 ofthe first and second legs 634, 636 in a manner biasing the second ends640, 644 of the first and second legs 634, 636, as well as the first end630 and second end 632 of the elongated member 628, from each other whenthey are not restrained in a manner discussed below in greater detail.

The first leg 634 and the second leg 636 are angularly oriented relativeto each other creating an elongated member 628 which is substantiallyV-shaped when the first leg 634 and the second leg 636 are allowed tomove away from each other based upon the outward bias inherent in theconnection member 637 between the first and second legs 634, 636. Theinherent bias in the connection members 637 is created through theutilization of spring materials or shape memory materials in theconstruction of the resilient body 618, in particular, the connectionmember 637.

With this in mind, the connection member 637 preferably includes asubstantially circular configuration with a first end 637 a connected tothe first end 638 of the first leg 634 and a second end 637 b connectedto the first end 642 of the second leg 636. The connection member 637 isformed with an inherent outward bias that forces the first leg 634 andthe second leg 636 outwardly upon deployment.

In addition, and in accordance with the preferred embodiment, the firstleg 634 and second leg 636 are formed with an outward bow when fullyextended. This outward bow stores further outward bias when theintrauterine device 610 is compressed for storage and deployment.

As discussed above, first and second extension arms 680, 682 are securedto the second ends 640, 644 of the first and second legs 634, 636 suchthat they extend beyond the first and second plug members 620, 622. Eachextension arm 680, 682 includes a first end 688, 690 secured to thesecond end 640, 644 of the first or second leg 634, 636 and a freesecond end 692, 694. The free second ends 692, 694 are respectivelyprovided with third and fourth plug members 624, 626.

As discussed above, each of the first and second extension arms 680, 682is formed with a resilient bias urging the first end 688, 690 and secondend 692, 694 (that is, increasing the radius of curvature of the arcdefined by the first and second extension arms 680, 682) thereof apartwhen the intrauterine device 610 is positioned within the uterine cavity16. While the first leg 634 and second leg 636 exhibit an outward bow,that is, convex inner surfaces facing each other when the intrauterinedevice 610 is deployed, the first and second extension arms 680, 682 areexactly the opposite with their concave surfaces facing each other whendeployed within the intrauterine cavity 16.

The present device offers a variety of other uses. These uses includeapplications for contraception, either temporary or permanent;especially for women who do not use IUDs because of the “postfertilization-embryo destruction” mechanism associated with the IUD'sbirth control. The present intrauterine device may also be used by womenwho do not wish to undergo a tubal ligation surgery.

In accordance with an alternate embodiment and with reference to FIG.44, the intrauterine device 210 is provided with an elongated member 218having hollow, tubular first and second legs 234, 236 allowing for thetransport of an injectable material to the plug members 220, 222. Assuch, and in accordance with this embodiment, the plug members 220, 222are made of a material (for example, a porous material) allowingtransport of the injectable material from the first and second legs 234,236, through the plug members 220, 222 and to the selected tissue.

As those skilled in the art will certainly appreciate, a variety ofembodiments have been disclosed above for implementation of the presentinvention. These various embodiments may be utilized alone or incombination, and various features may be combined to achieve resultsremaining within the spirit of the present invention.

While the preferred embodiments have been shown and described, it willbe understood that there is no intent to limit the invention by suchdisclosure, but rather, is intended to cover all modifications andalternate constructions falling within the spirit and scope of theinvention.

1. An intrauterine device for applying pressure to the walls of theuterine cavity, the intrauterine device comprising: a resilient bodyincluding an elongated member having a first end and a second end whichare resiliently biased away from each other, the first end of theelongated member including a first leg having a first end and a secondend, and the second end including a second leg having a first end and asecond end, wherein a connection member is positioned between the firstend of the first leg and the first end of the second leg; a first plugmember secured at the second end of the first leg and a second plugmember secured at the first end of the second leg, the first and secondplug members being shaped and dimensioned for bearing against the wallsof the uterine cavity as the elongated member spreads outwardly with thefirst end and the second end moving apart.
 2. The intrauterine deviceaccording to claim 1, wherein the elongated member extends between afolded configuration when stored for deployment and a deployedconfiguration when the first and second plug members are positionedagainst the walls of the uterine cavity.
 3. The intrauterine deviceaccording to claim 1, wherein the first leg includes a first end and asecond end, the second end being connected to the first plug member, andthe second end of the first leg includes a reduced diameter sectionallowing for greater flexibility in an area adjacent the first plugmember, and the second leg includes a first end and a second end, thesecond end being connected to the second plug member, and the second endof the second leg includes a reduced diameter section allowing forgreater flexibility in an area adjacent the second plug members.
 4. Theintrauterine device according to claim 1, wherein the first and secondplug members respectively apply a force of at least approximately 0.01ft·lb to the lateral walls of the uterine cavity.
 5. The intrauterinedevice according to claim 4, wherein the first plug member and thesecond plug member are composed of materials encouraging tissuein-growth.
 6. The intrauterine device according to claim 4, wherein theapplied force is between approximately 0.01 ft·lb and approximately0.025 ft·lb.
 7. The intrauterine device according to claim 1, whereinthe first plug member and the second plug member are composed ofmaterials encouraging tissue in-growth.
 8. The intrauterine deviceaccording to claim 7, wherein the first plug member and the second plugmember are composed of bioresorbable materials.
 9. The intrauterinedevice according to claim 1, wherein the first plug member and thesecond plug member are composed of bioresorbable materials.
 10. Theintrauterine device according to claim 1, wherein the resilient bodyincludes a first extension arm extending from the second end of thefirst leg and a second extension arm extending from the second end ofthe second leg.
 11. The intrauterine device according to claim 10,wherein the first extension arm is resiliently biased and the secondextension arm is resiliently biased.
 12. The intrauterine deviceaccording to claim 10, wherein the first extension arm includes a firstend coupled to the second end of the first leg and the second extensionarm includes a first end coupled to the second end of the second leg.13. The intrauterine device according to claim 12, wherein a third plugmember is secured to the second end of the first extension arm and afourth plug member is secured to the second end of the second extensionarm.
 14. The intrauterine device according to claim 12, wherein thefirst extension arm is substantially C-shaped and the second endextension arm is substantially C-shaped, wherein a concave portion ofthe first extension arm faces a concave portion of the second extensionarm.
 15. The intrauterine device according to claim 1, wherein the plugmembers are impregnated with medicine.
 16. A method for preventingconception within the uterine cavity, comprising the following steps:delivering an intrauterine device into the uterine cavity, theintrauterine device including an elongated member with a first end andsecond end, and a first plug member secured at the first end of theelongated member and a second plug member secured at the second end ofthe elongated member; causing the intrauterine device to apply pressurewithin the uterine cavity in a manner that will alter the shape of theuterine cavity over time thus preventing conception.
 17. The methodaccording to claim 16, further including the step of causing irritationand encouraging tissue in-growth into the first plug member and thesecond plug member.
 18. The method according to claim 16, wherein thefirst and second plug members respectively apply a force of at leastapproximately 0.01 ft·lb to the lateral walls of the uterine cavity. 19.The method according to claim 18, wherein the load applied is betweenapproximately 0.01 ft·lb and approximately 0.025 ft·lb.
 20. The methodaccording to claim 16, wherein the first plug member and the second plugmember are composed of materials encouraging tissue in-growth.
 21. Themethod according to claim 16, wherein the resilient body includes afirst extension arm extending from the second end of the first leg and asecond extension arm extending from the second end of the second leg.22. The method according to claim 21, wherein the first extension arm isresiliently biased and the second extension arm is resiliently biased.23. The method according to claim 21, wherein the first extension armincludes a first end coupled to the second end of the first leg and thesecond extension arm includes a first end coupled to the second end ofthe second leg, and wherein the second end of the first extension arm isshaped and dimensioned for applying pressure to an upper wall of theuterine cavity and the second end of the second extension arm is shapedand dimensioned for applying pressure to the upper wall of the uterinecavity.
 24. The method according to claim 23, where a third plug memberis secured to the second end of the first extension arm and a fourthplug member is secured to the second end of the second extension arm.25. The method according to claim 23, wherein the first extension arm issubstantially C-shaped and the second end extension arm is substantiallyC-shaped, wherein a concave portion of the first extension arm faces aconcave portion of the second extension arm.
 26. The method according toclaim 16, wherein the first and second plug members are positioned onthe lateral walls of the uterine cavity, below respective orifices offallopian tubes.
 27. The method according to claim 16, wherein the plugmembers are impregnated with medicine.
 28. A method for delivering anintrauterine device, comprising: advancing the intrauterine device intothe uterine cavity, the intrauterine device including an elongatedmember with a first end and second end, and a first plug member securedat the first end of the elongated member and a second plug membersecured at the second end of the elongated member; releasing theintrauterine device, release resulting in (a) the first and second plugmembers first moving outwardly due to stored outward bias in theelongated member, (b) the first and second plug members then movingupwardly within the uterine cavity, (c) the first and second plugmembers then moving into contact with respective opposed walls of theuterine cavity and (d) the first and second plug members applyingpressure to respective opposed walls of the uterine cavity to preventconception within the uterine cavity.
 29. The method according to claim28, wherein the resilient body includes a first extension arm extendingfrom the second end of the first leg and a second extension armextending from the second end of the second leg.
 30. The methodaccording to claim 29, wherein the first extension arm is resilientlybiased and the second extension arm is resiliently biased.
 31. Themethod according to claim 29, wherein the first extension arm includes afirst end coupled to the second end of the first leg and the secondextension arm includes a first end coupled to the second end of thesecond leg, and wherein the second end of the first extension arm isshaped and dimensioned for applying pressure to an upper wall of theuterine cavity and the second end of the second extension arm is shapedand dimensioned for applying pressure to the upper wall of the uterinecavity.
 32. The method according to claim 31, wherein a third plugmember is secured to the second end of the first extension arm and afourth plug member is secured to the second end of the second extensionarm.
 33. The method according to claim 31, wherein the first extensionarm is substantially C-shaped and the second end extension arm issubstantially C-shaped, wherein a concave portion of the first extensionarm faces a concave portion of the second extension arm.
 34. The methodaccording to claim 28, wherein the first and second plug members arepositioned on the lateral walls of the uterine cavity, below respectiveorifices of fallopian tubes.
 35. The method according to claim 28,wherein the plug members are impregnated with medicine.
 36. A method forpreventing conception within the uterine cavity, comprising thefollowing steps: delivering an intrauterine device into the uterinecavity for positioning between lateral walls of the uterine cavity, theintrauterine device including an elongated member with a first end andsecond end, and a first plug member secured at the first end of theelongated member and a second plug member secured at the second end ofthe elongated member; causing the intrauterine device to expand withinthe uterine cavity such that a distance between the first plug memberand the second plug member is greater than the distance between opposedlateral walls of the uterine cavity.
 37. The method according to claim36, wherein the first and second plug members respectively apply a forceof at least approximately 0.01 ft·lb to the lateral walls of the uterinecavity.
 38. The method according to claim 37, wherein the load appliedis between approximately 0.01 ft·lb and approximately 0.025 ft·lb. 39.The method according to claim 36, wherein the resilient body includes afirst extension arm extending from the second end of the first leg and asecond extension arm extending from the second end of the second leg.40. The method according to claim 39, wherein the first extension arm isresiliently biased and the second extension arm is resiliently biased.41. The method according to claim 39, wherein the first extension armincludes a first end coupled to the second end of the first leg and thesecond extension arm includes a first end coupled to the second end ofthe second leg, and wherein the second end of the first extension arm isshaped and dimensioned for applying pressure to an upper wall of theuterine cavity and the second end of the second extension arm is shapedand dimensioned for applying pressure to the upper wall of the uterinecavity.
 42. The method according to claim 41, wherein a third plugmember is secured to the second end of the first extension arm and afourth plug member is secured to the second end of the second extensionarm.
 43. The method according to claim 42, wherein the first extensionarm is substantially C-shaped and the second end extension arm issubstantially C-shaped, wherein a concave portion of the first extensionarm faces a concave portion of the second extension arm.
 44. The methodaccording to claim 36, wherein the first and second plug members arepositioned on the lateral walls of the uterine cavity, below respectiveorifices of fallopian tubes.
 45. The method according to claim 36,wherein the plug members are impregnated with medicine.